US FDA approves Ibsrela for irritable bowel syndrome

Californian cardiorenal specialist Ardelyx (Nasdaq: ARDX) has won US approval for Ibsrela (tenapanor), an oral treatment for irritable bowel syndrome with constipation (IBS-C) in adults.

The approval was based on positive data from two clinical trials, T3MPO-1 and T3MPO-2, and one long-term safety extension trial, T3MPO-3.

The minimally-absorbed small molecule acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients.